Identity
- Trade Name
- Herculite XRV Ultra EUDAMED
- Device Name
- Herculite XRV Ultra EUDAMED
- Model / Reference
- 34021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051511874248 EUDAMED
- Basic UDI-DI
- 80515118710000204W EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
Herculite XRV Ultra by Kerr Italia Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80515118710000204W | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kerr Italia Srl
- EUDAMED SRN
- IT-MF-000007768
Sources (1)
- EUDAMED c804b24c-8063-40d0-976a-05d0315c7066 61 fields · synced Jun 19, 2026